DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-12 are pending in the instant application. Claims 3, 5-6 and 8-11 are amended and claim 12 is added via the amendment filed October 21st, 2024.
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/CN2023/088864 filed April 18th, 2023, which claims priority under 35 U.S.C. 119(a-d) to CN202210408886.8, filed April 19th, 2022. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d)
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed October 31st, 2024 was considered by the Examiner.
Claim Objections
Claim 7 is objected to because of not being in proper Markush formation. The phrase “from the following compounds” in line 2 of the claim should be replaced with “from the group consisting of” and “and” should be inserted before the last compound depicted in the claim
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 8-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for tautomer or pharmaceutically acceptable salt, does not reasonably provide enablement for solvate.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Factors to be considered in making an enablement rejection are summarized as: a) the quantity of experimentation necessary, b) the amount of direction or guidance presented, c) the presence or absence of working examples, d) the nature of the invention, e) the state of the prior art, f) the relative skill of those in the art, g) the predictability or unpredictability of the art, and h) the breadth of the claims.
The instant claims recite a compound of formula I or “a tautomer, a solvate or a pharmaceutically acceptable salt thereof”.
The claims, insofar as they embrace solvates are not enabled. The present specification merely mentions the Applicant’s intention to make solvates, without teaching the preparation thereof. As stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190, 1194 (Fed.Cir. 1993):
The specification purports to teach, with over fifty examples, the preparation of the claimed compounds ... However ... there is no evidence that such compounds exist ... [T]he examples ... do not produce the postulated compounds ... [T]here is ... no evidence that such compounds even exist.
The same circumstance appears to be true here. There is no evidence that solvates of these compounds actually exist; if they did, they would have formed. Hence, applicants must show that solvates can be made, or limit the claims accordingly.
See MPEP 2164.01(a), discussed supra, justifying the conclusion of lack of enablement commensurate with the claims. Without guidance in the present application, undue experimentation will be required to practice Applicant’s claimed invention.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 11-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites “the anions include but are not limited to…”. This phrase leaves the metes and bounds of the claim unclear. It is not clear if the anions only include those listed in the claim and/or to what extent the list of anions reaches beyond those listed in the claim.
Claims 11-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: as to how the manufacture is performed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6 and 8-12 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ye et al (WO 2017/012556 A1, published January 26th, 2017).
Regarding claim 1, Ye teaches the following compound (page 4, compound d-1):
PNG
media_image1.png
109
159
media_image1.png
Greyscale
.
This compound is embraced by instant formula (I), wherein R1 is H and R2 is
PNG
media_image2.png
39
300
media_image2.png
Greyscale
, wherein n4 is 1, n5 is 0 and n6 is 0.
Regarding claims 2-3, R1 is H and R2 is
PNG
media_image2.png
39
300
media_image2.png
Greyscale
, wherein n4 is 1, n5 is 0 and n6 is 0.
Regarding claim 6, the claim recites limitations to R3, R4 and R5, however, as the compound above does not have these variables, the compound is embraced by the claim.
Regarding claims 8-9, the claims recite limitations to the pharmaceutically acceptable salt of instant formula (I), however the compound above is not a salt and thus, still embraced by the claims.
Regarding claim 10, Ye teaches that the compound above is formula as a pharmaceutical composition with a pharmaceutically acceptable adjuvant.
Regarding claims 11-12, Ye teaches that the pharmaceutical composition comprising the compound above can be used for medical use in the preparation of a medicament for treating diseases including antipyretic.
Claim(s) 1, 4-6 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Miyamoto et al (US 2019/0184023 A1, published June 9th, 2019).
Miyamoto teaches the following compound (page 34, Scheme 14):
PNG
media_image3.png
101
193
media_image3.png
Greyscale
.
Regarding claim 1, this compound is embraced by instant formula (I), wherein R1 is
PNG
media_image4.png
15
277
media_image4.png
Greyscale
, whereon n1 is 1, n2 is 0 and n3 is 0 and R2 is H.
Regarding claims 4-5, R1 is
PNG
media_image4.png
15
277
media_image4.png
Greyscale
, whereon n1 is 1, n2 is 0 and n3 is 0 and R2 is H.
Regarding claim 6, the claim recites limitations to R3, R4 and R5, however, as the compound above does not have these variables, the compound is embraced by the claim.
Regarding claims 8-9, the claims recite limitations to the pharmaceutically acceptable salt of instant formula (I), however the compound above is not a salt and thus, still embraced by the claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
Prosecution Insights